Status:
COMPLETED
PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Pierre and Marie Curie University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI
Detailed Description
PET/CT with FDG-(18F) and FLT-(18F) and MRI are performed at the initial staging, 3 times during sequential adjuvant chemotherapy and prior to surgery, aiming to find the most efficient modality to pr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery
- Exclusion criteria:
- Indicated chemotherapy without that a curative tumorectomies is foreseen(planned)
- Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG
- Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes)
- Diabetic waits
- Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations
- Patient not having given her lit(enlightened) assent
- Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol)
- Of less than 18 years old or pregnant patient.
- Breast cancer stage(stadium) IV
- Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j.
- In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00236275
Start Date
May 1 2004
End Date
December 1 2007
Last Update
May 2 2011
Active Locations (1)
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1
Hôpital TENON
Paris, France, 75020